Product Development Manager Medical Devices - IVD

Job description

We are looking for amazing, talented and high energy people to join the team of SPEKTRAX to grow the company.

You will be the leading the product development of our IVD solution, one of the key people in the company for bringing our testkit to the market. You will be responsible for a multidisciplinary product including consumables, integration with existing hardware, data modelling and machine learning. We need to be able to trust you to deliver and be self-propelling.

As we are in a fast track you will be working in an ultra-fast paced environment which is very exciting, but also requires flexibility.

Providing project management and hands-on support to the technical, quality control and assurance, bioinformatics, regulatory, and manufacturing aspects. Compliance according to ISO 13485 and other standards.

  • Provide leadership in the development and coordination of a multidisciplinary team, defining key deliverables, milestones, dependencies, according to the Design and Development plan.
  • Supervise team members in the development and documentation of design inputs and outputs with appropriate collaboration and coordination with R&D, data modelling, software dev, manufacturing and lab operations.
  • Actively participate in, and seek input from, cross-functional teams to ensure alignment on a clear roadmap.
  • Participate in developmental and regulatory strategies to commercialize our in vitro diagnostic solution.
  • Supervise creation of design control documentation that meet standards required for inclusion in required regulatory dossiers.
  • Ideal if you have: Knowledge of bioinformatics, specifically chemometrics and ML

    You will be involved in a lot of what is happening in the company so confidentiality and discretion are crucial characteristics we are looking for.

    We have a very open and transparent way of working and don't have a hierarchical structure. If you are the type of person that will need a very detailed job-description, SPEKTRAX is not for you. We need people who will pro-actively pick up the ball and start running with it! 

    If this appeals to you! Call or email us today!

    About SPEKTRAX:

    We are a young company with a mission to 'democratise diagnostics'. This means that we aim to make tests for illnesses, bacteria and viruses available to the world. Making sure we maintain our high standards in the quality of our test is of course a key focus of our company. Currently we are 

    focussing on bringing a new and ultra fast COVID-19 test on the market. We are using amazing laser and nano technology to do this. Part high tech, part software and part driven by the desire to impact the world, we work hard every day to make a difference. If you share our excitement about our mission, come and join us and build a dream! Hope to see you soon!

    Job requirements

    Education: HBO or higher education, (Bio)informatics, AI, Chemometrics, Data management. 

    Experience: 8+ years working experience, preferably in a start-up or scale-up environment

    Languages: English 


    Well structured and precise
    Project management skills

    EU working permit

    Locations: Delft